MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion
- Serves as the subject matter expert on biocompatibility
- Responsible for review of biocompatibility/risk assessments reports, literature search & reviews, writing summary reportsand assist regulatory affairs on regulatory submissions
- Must have in-depth understanding of engineering and scientific principles, materials, manufacturing processes, biocompatibility standards, and sterilization methods
- Provide guidance for early phase evaluations, new product development, and legacy projects on Biocompatibility testing requirements based on international standards
- Liaise with internal team &external contacts (client), if required to collect all the relevant information of raw materials,semi or finished products
- Communicates effectively with the project team(s) and management
- Acts as a resource or mentor for other coworkers with less experience
- Activities may include attending meetings, making presentations etc.
Bachelor of Science in Medicinal chemistry or Biomedical Engineering/ Material Science/ Analytical Chemistry
? 3 – 5 years of experience in a biomed role
? At least 2 years of experience in the area of toxicology, biocompatibility testing and risk assessments according to ISO 10993 will be highly preferred
MakroCare | A MakroGroup Company | www.MakroCare.com
MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
MakroCare Awarded as:
- Best Biopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma
- Best Pharmaceutical Strategic Development Specialist - UK Enterprises
- The Outstanding Consulting Firm - Insights Success
- AI Excellence in Regulatory & Automation Solutions - Acquisition International
- AI Excellence in Best Bio Pharma Development Partner - Acquisition International
- Best Practices Award - Clinical Informatics
- NJ Excellence Award - US Institute for Excellence in Commerce
- Best Biotech Award - US Commerce Association
- Clinical Research Team and Best Technological Development in Clinical Trials Finalists - Scrip Awards
- Circle Of Excellence – MerchantCircle
About MakroGroup | www.MakroGrp.com
Makro Group of Organizations established in 1996, Makro provides a complete range of solutions for every stage of business and information lifecycle.
- MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
- DDi Awarded by Insights Success, CIO, Corporate LiveWire, Pharma Tech Outlook, Clinical Informatics & SCRIP
- MakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company & TOP 100 diversity business in NJ
- MakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSR Initiative, has counseled over 3000 people.